PIONEER PLUS CATHETER

Additional Manufacturer Narrative

THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCKS A2, A3B-A6: AGE, DATE OF BIRTH, GENDER, WEIGHT, ETHNICITY AND RACE, NOT AVAILABLE FROM FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS H3 & H6: THE PIONEER CATHETER WAS NOT RETURNED, THUS NO PRODUCT INVESTIGATION WAS PERFORMED. ADDITIONALLY, THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND ALL RELEASED UNITS WERE MANUFACTURED TO SPECIFICATION, WITH NO NCRS OR DEVIATIONS CONTRIBUTING TO THE REPORTED COMPLAINT. BLOCKS H7, H9 & H10: DO NOT APPLY TO THIS SUBMISSION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

Description of Event or Problem

IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, THE NEEDLE WAS SUCCESSFULLY DEPLOYED INTO THE VESSEL; HOWEVER, ATTEMPTS TO RETRACT THE NEEDLE WAS NOT POSSIBLE. THE CATHETER WAS REMOVED WITH NO PATIENT INJURY REPORTED. DUE TO THE FAILED CATHETER, THE PATIENT WILL BE BROUGHT BACK AT A LATER DATE. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A SHARP EDGE AND DELAY OF PROCEDURE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WAS TO RECUR.